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临床试验/NCT06151041
NCT06151041尚未招募不适用

Microneedling Combined With Either Tranexamic Acid or PRP in Treatment of Pigmented Postacne Scars : A Split Face Comparative Study

Assiut University0 个研究点目标入组 40 人开始时间: 2023年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
To evaluate the comparison between the efficacy of Microneedling combined with Tranexmic acid on the right side of the face and efficacy of PRP on the left side of the face in treatment of pigmented post acne scars

研究概览

简要总结

To evaluate the efficacy of Microneedling combined with Tranxemic acid compared with Micronedlling with PRP in treatment of Pigmented Post Acne Scars.

详细描述

Acne is a multifactorial chronic inflammatory disease of pilosebaceous unit, clinically characterised by the presence of comedones, inflammatory papules, pustules and sometimes nodules and cysts. It commonly occurs during adolescence and cause great psychological stress. Unfortunately, acne scarring is common and occurs easily in the course of the disease. It is one of the most common causes of facial scarring and treating acne scar is one of the most challenging cosmetic procedures . Patient with acne vulgaries is not only experience the primary inflammatory and non-inflammatory lesions, but also have secondary lesions such as scars, excoriations, post-inflammatory erythema, and dyspigmentation. Acne scars are pleomorphic and difficult to count or even photograph, and consensus concerning acne scar nomenclature and classification remains a matter of debate .

The pathophysiology driving acne scar development is attributed to an altered wound healing response initiated by cutaneous inflammation, leading to an imbalance in matrix degradation and collagen biosynthesis .

The ultimate severity is correlated with acne grade and delay in treatment of active disease . The end result is either an excess of collagen that manifests as hypertrophic/keloid scars or, more commonly, decreased collagen deposition that manifests as atrophic acne scars in 80 to 90 percent of cases.

Tranexamic acid (TXA); a plasmin inhibitor used to prevent fibrinolysis to reduce blood loss , is now gaining popularity as a depigmenting agent as it can block melanin synthesis in melanocytes by inhibiting plasmin-plasminogen system , as well as competitive-inhibition of tyrosinase activity due to its similarity to tyrosine structure .

Microneedling has been used to treat various dermatologic conditions, including scars, rhytides, and dyschromia . The treatment causes small channels of epidermal and dermal injury through the use of needles that puncture the skin . The damaged collagen is removed, and new growth and remodeling subsequently occur . The release of platelet-derived growth factors, fibroblasts, and elastic fiber formation contribute to neovascularization and neocollagenesis ..

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 40 Male or Female healthy patient with Pigmented facial acne scars.
  • Age of patient 18 -35 years old .
  • Co-operative patients .
  • No history of allergy to traneximc acid .
  • No history of bleeding disorder

排除标准

  • Presence of active Acne Lesions .
  • Patients having Keloid scaring and Keloid tendency .
  • History of bleeding disorder.
  • History of anticoagulant therapy.
  • Active Skin infection like Warts , Hereps , Bacterial infection .
  • Pregenancy and Lactation .
  • Patients below 18 years .
  • History of laser treatment or any other acne therapy within one month .
  • Use of any acne medication in oral and topical forms , including retiniods , antibiotics

结局指标

主要结局

To evaluate the comparison between the efficacy of Microneedling combined with Tranexmic acid on the right side of the face and efficacy of PRP on the left side of the face in treatment of pigmented post acne scars

时间窗: 1 year

To evaluate the comparison between the efficacy of Microneedling combined with Tranexmic acid on the right side of the face and efficacy of PRP on the left side of the face in treatment of pigmented post acne scars in 1 year and this evaluation can be measured by a Questionnaire throught study completion and take photograghes each session .

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reham Youssef Mahmoud Moustafa

prof / Doaa samir sayed

Assiut University

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